Business Wire

Kite Announces Two-Year Data for Yescarta® (Axicabtagene Ciloleucel) in Patients With Refractory Large B-Cell Lymphoma

Jaa

Kite, a Gilead Company (Nasdaq: GILD), announced two-year efficacy and safety data from the pivotal ZUMA-1 trial of Yescarta® (axicabtagene ciloleucel) in patients with refractory large B-cell lymphoma. With a minimum follow-up of two years after a single infusion of Yescarta (median follow up of 27.1 months), 39 percent of patients were in an ongoing response. This updated analysis with at least 24 months of follow-up was presented at the Annual Meeting of the American Society of Hematology (ASH; Abstract #2967) and simultaneously published in The Lancet Oncology.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181202005058/en/

In October 2017, Yescarta became the first chimeric antigen receptor T (CAR T) cell therapy to be approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma (PMBCL), high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. The U.S. Prescribing Information for Yescarta contains a Boxed Warning regarding the risk of cytokine release syndrome (CRS) and neurologic toxicities; see below for Important Safety Information.

At two years, the best objective response via investigator assessment (n=101) showed an overall response rate of 83 percent, with 58 percent of patients having achieved a complete response. With a median follow-up of 27.1 months, 39 percent of patients remained in response. Of the patients with an ongoing response at 12 months, 93 percent remained in response at 24 months. The median duration of response was 11.1 months; the median duration of complete response was not reached. Median overall survival was not reached.

“With aggressive cancers such as refractory large B-cell lymphoma, our primary goal is to extend the lives of patients,” said Sattva S. Neelapu, MD, ZUMA-1 Co-Lead Investigator and Professor, Department of Lymphoma/Myeloma, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center. “Outcomes with traditional standard of care for this highly refractory patient population have been extremely poor. Nearly 40 percent of patients in ZUMA-1 remain in response and half of the patients are still alive after at least two years of treatment with Yescarta.”

In the two-year analysis (n=108), Grade 3 or higher CRS and neurologic events were seen in 11 percent and 32 percent of patients, respectively, and were generally reversible. Four patients developed new serious adverse events (occurring since the previous August 11, 2017 data cutoff), none of which were related to Yescarta. No new Yescarta-related CRS or neurologic events or deaths have occurred since the one-year analysis.

“The two-year point is a another major milestone for Yescarta, which has extended the lives of a significant number of patients in ZUMA-1 and has yielded important learnings that inform further research and development of CAR T therapies,” said Alessandro Riva, MD, Executive Vice President, Oncology Therapeutics and Head, Cell Therapy, Gilead Sciences. “These data are not only significant for the lymphoma community, but also reinforce our leadership in cell therapy as we aim to transform the treatment of a variety of cancers with other investigational therapies in our pipeline.”

Full study results are available in The Lancet Oncology:

Long-term safety and activity of axicabtagene ciloleucel in refractory large B-cell lymphoma (ZUMA-1): a single-arm, multicentre, phase 1–2 trial: http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(18)30864-7/fulltext

U.S. Important Safety Information for Yescarta

BOXED WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITIES

  • Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving Yescarta. Do not administer Yescarta to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
  • Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving Yescarta, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with Yescarta. Provide supportive care and/or corticosteroids as needed.
  • Yescarta is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Yescarta REMS.

CYTOKINE RELEASE SYNDROME (CRS): CRS occurred in 94% of patients, including 13% with ≥ Grade 3. Among patients who died after receiving Yescarta, 4 had ongoing CRS at death. The median time to onset was 2 days (range: 1-12 days) and median duration was 7 days (range: 2-58 days). Key manifestations include fever (78%), hypotension (41%), tachycardia (28%), hypoxia (22%), and chills (20%). Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), cardiac arrest, cardiac failure, renal insufficiency, capillary leak syndrome, hypotension, hypoxia, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome. Ensure that 2 doses of tocilizumab are available prior to infusion of Yescarta. Monitor patients at least daily for 7 days at the certified healthcare facility following infusion for signs and symptoms of CRS. Monitor patients for signs or symptoms of CRS for 4 weeks after infusion. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab or tocilizumab and corticosteroids as indicated.

NEUROLOGIC TOXICITIES: Neurologic toxicities occurred in 87% of patients. Ninety-eight percent of all neurologic toxicities occurred within the first 8 weeks, with a median time to onset of 4 days (range: 1-43 days) and a median duration of 17 days. Grade 3 or higher occurred in 31% of patients. The most common neurologic toxicities included encephalopathy (57%), headache (44%), tremor (31%), dizziness (21%), aphasia (18%), delirium (17%), insomnia (9%) and anxiety (9%). Prolonged encephalopathy lasting up to 173 days was noted. Serious events including leukoencephalopathy and seizures occurred with Yescarta. Fatal and serious cases of cerebral edema have occurred in patients treated with Yescarta. Monitor patients at least daily for 7 days at the certified healthcare facility following infusion for signs and symptoms of neurologic toxicities. Monitor patients for signs or symptoms of neurologic toxicities for 4 weeks after infusion and treat promptly.

YESCARTA REMS: Because of the risk of CRS and neurologic toxicities, Yescarta is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Yescarta REMS. The required components of the Yescarta REMS are: Healthcare facilities that dispense and administer Yescarta must be enrolled and comply with the REMS requirements. Certified healthcare facilities must have on-site, immediate access to tocilizumab, and ensure that a minimum of 2 doses of tocilizumab are available for each patient for infusion within 2 hours after Yescarta infusion, if needed for treatment of CRS. Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense or administer Yescarta are trained about the management of CRS and neurologic toxicities. Further information is available at www.YESCARTAREMS.com or 1-844-454-KITE (5483).

HYPERSENSITIVITY REACTIONS: Allergic reactions may occur. Serious hypersensitivity reactions including anaphylaxis may be due to dimethyl sulfoxide (DMSO) or residual gentamicin in Yescarta.

SERIOUS INFECTIONS: Severe or life-threatening infections occurred. Infections (all grades) occurred in 38% of patients, and in 23% with ≥ Grade 3. Grade 3 or higher infections with an unspecified pathogen occurred in 16% of patients, bacterial infections in 9%, and viral infections in 4%. Yescarta should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after Yescarta infusion and treat appropriately. Administer prophylactic anti-microbials according to local guidelines. Febrile neutropenia was observed in 36% of patients and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad spectrum antibiotics, fluids and other supportive care as medically indicated. Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, can occur in patients treated with drugs directed against B cells. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing.

PROLONGED CYTOPENIAS: Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and Yescarta infusion. Grade 3 or higher cytopenias not resolved by Day 30 following Yescarta infusion occurred in 28% of patients and included thrombocytopenia (18%), neutropenia (15%), and anemia (3%). Monitor blood counts after Yescarta infusion.

HYPOGAMMAGLOBULINEMIA: B-cell aplasia and hypogammaglobulinemia can occur. Hypogammaglobulinemia occurred in 15% of patients. Monitor immunoglobulin levels after treatment and manage using infection precautions, antibiotic prophylaxis and immunoglobulin replacement. The safety of immunization with live viral vaccines during or following Yescarta treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during Yescarta treatment, and until immune recovery following treatment.

SECONDARY MALIGNANCIES: Patients may develop secondary malignancies. Monitor life-long for secondary malignancies. In the event that a secondary malignancy occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to collect for testing.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: Due to the potential for neurologic events, including altered mental status or seizures, patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following Yescarta infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period.

ADVERSE REACTIONS: The most common adverse reactions (incidence ≥ 20%) include CRS, fever, hypotension, encephalopathy, tachycardia, fatigue, headache, decreased appetite, chills, diarrhea, febrile neutropenia, infections-pathogen unspecified, nausea, hypoxia, tremor, cough, vomiting, dizziness, constipation, and cardiac arrhythmias.

About Kite

Kite, a Gilead Company, is a biopharmaceutical company based in Santa Monica, California. Kite is engaged in the development of innovative cancer immunotherapies. The company is focused on chimeric antigen receptor and T cell receptor engineered cell therapies. For more information on Kite, please visit www.kitepharma.com.

About Gilead Sciences

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. For more information on Gilead Sciences, please visit the company’s website at www.gilead.com .

Forward-Looking Statement

This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility of unfavorable results from ongoing and additional clinical trials involving Yescarta. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2018, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead and Kite, and Gilead and Kite assume no obligation to update any such forward-looking statements.

U.S. Prescribing Information for Yescarta, including BOXED WARNING and Medication Guide, is available at www.kitepharma.com and www.gilead.com .

Yescarta is a registered trademark of Gilead Sciences, Inc., or its related companies.

For more information on Kite, please visit the company’s website at  www.kitepharma.com . Learn more about Gilead at www.gilead.com , follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Contact information

Sung Lee, Investors
(650) 524-7792

Nathan Kaiser, Media
(650) 522-1853

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Cred Opens Its Platform to Developers and Businesses10.12.2018 23:21Tiedote

Cred, the leading provider of crypto-backed lending with over $300 million in credit facilities, today announced the launch of CredX, Cred’s developer platform, enabling any company or developer to turn their products into powerful financial applications for their customers. Crypto exchanges, crypto wallets, miner service providers, even traditional financial institutions have the ability to access Crypto Lending as a Service (CLaaS™) and create a rich set of customer experiences for their customers. “Lending and Earning Crypto are hard businesses to get right, particularly in a bear market,” said Dan Schatt, Co-Founder of Cred and the Universal Protocol Alliance. “A crypto custodian, wallet, merchant or exchange business can now offer their customers compelling credit and treasury management features built directly into their own apps, powered by Cred. Businesses can choose to use their own balance sheets, or leverage Cred’s to provide credit and earning services to generate revenue,

Axonics® Announces Publication of NICE Briefing10.12.2018 19:03Tiedote

Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company focused on the development and commercialization of novel implantable Sacral Neuromodulation (“SNM”) devices for the treatment of urinary and bowel dysfunction, announced today the publication of a Medtech Innovation Briefing by The National Institute for Health and Care Excellence (“NICE”) following a careful review of the innovations offered by the Axonics System. The NICE Medtech Innovation Briefing entitled: “Axonics rechargeable sacral neuromodulation system for overactive bladder and faecal incontinence,” describes published clinical evidence on the Axonics r-SNM System®, confirming efficacy as well as the potential positive economic impact that is possible by the use of the Axonics system in the United Kingdom. The Axonics r-SNM System is the first rechargeable Sacral Neuromodulation system approved for sale in Europe and commercially available to all hospitals and clinics in the U.K. for patients

The Largest Blockchain Conference in Asia to Be Held 30–31 January in Yokohama, Japan10.12.2018 18:00Tiedote

The Global Blockchain Association (Shimizu Building 6F, 3-19 Hayabusacho, Chiyoda-ku, Tokyo, President: Toshikazu Masuyama) is proud to host the largest blockchain conference in Asia: The Japan Blockchain Conference (JBC) – 2019 Yokohama, to be held on 30 and 31 January at Pacifico Yokohama. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181210005057/en/ The Japan Blockchain Conference (JBC) - 2019 Yokohama (Graphic: Business Wire) The conference will host top companies and organizations from Japan and abroad who represent the future of the rapidly growing blockchain space. This is the place where the leaders of blockchain and crypto can interact, form partnerships, and showcase their leading technologies and developments. We are actively looking for companies to join the best of the blockchain industry and exhibit at our conference. More details can be found here: http://japan-blockchain-c.com/en/ We welcome a wide range of

Global Payments’ TouchNet Business Named “Partner of the Year” by Ellucian10.12.2018 16:30Tiedote

Global Payments Inc. (NYSE: GPN), a leading worldwide provider of payment technology and software solutions is pleased to announce that its TouchNet business was named “Partner of the Year” by Ellucian, a provider of software and services that power higher education, at its Partner Forum reception during the annual EDUCAUSE Conference this year in Denver, CO. TouchNet was recognized for its collaborative efforts to deliver streamlined engaging, cloud-based, student commerce and credential solutions. This honor further demonstrates the depth and breadth of the TouchNet platform and its dedication to delivering software-driven and technology-enabled strategies to institutions of higher education. “TouchNet’s commitment to delivering maximum value enables Ellucian to consistently provide customers with best-in-class solutions, support and service,” said Chris Westfall, Vice President Partnerships Ellucian. “When you combine Ellucian’s feature rich technology and in-depth customer knowledg

CTS Engines Hires Tom Bode as Senior Vice President, Operations10.12.2018 16:00Tiedote

CTS Engines, the global leader for mature engine maintenance within the Aerospace & Defense industry, announced today that it had hired Tom Bode as its Senior Vice President, Operations. In his new role, Mr. Bode will be responsible for all operations, quality, and engineering functions, and will report to Vesa Paukkeri, CTS Engines’s President and COO. Since 2008, Mr. Bode has been the General Manager of the Columbus Engine Center for Pratt & Whitney, a company he joined in 2000. Prior to 2000, Mr. Bode worked at GE Aviation, where he was a quality and engineering leader. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181210005036/en/ Tom Bode (Photo: Business Wire) “As the General Manager of CEC, Tom managed over 700 employees across multiple engine production lines and reduced overhaul turnaround times through the promotion of Lean manufacturing principles,” said Mr. Paukkeri. “His performance as a manager was recognized

Tracxpoint Signed a Major Agreement to Deploy its Artificial Intelligence Cart (AiC®) Platform at CONAD, One of the Largest and Most Sophisticated Supermarket Chains in Italy with 3,000 Locations in Lieu of Amazon Go after Intensive Study10.12.2018 14:00Tiedote

Tracxpoint, a global provider of next-generation self-checkout grocery solutions, today announced an agreement to roll out its Artificial Intelligence Cart (AiC®) at CONAD DEL TIRRENO, one of the seven cooperatives of CONAD’s chain with more than 3,000 supermarket stores in Italy. This is a major milestone for the Israeli startup in its mission to establish the AiC® platform as the most powerful, accessible and comprehensive solution for self-checkout and personalized in-store engagement on the market today. CONAD DEL TIRRENO will start implementing the AiC® ecosystem during 2019. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181210005176/en/ The Tracxpoint AiC enables checkout-free stores and personalized in-store engagement for Italy's largest supermarket chain, CONAD. (Photo: Business Wire) In direct contrast to capital-intensive and smaller store concepts like Amazon Go or its imitators that rely on ceiling cameras for

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme